New Technologies in the Rehabilitation of Chronic Stroke

Feasibility and Cost Description of Intensive Rehabilitation Involving New Technologies in Patients With Sub-acute Stroke:A Multicenter Single Arm Trial of the Swiss RehabTech Initiative

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03641651

Acronym

SRTI

Enrollment

Registered

2018-08-22

Start date

2018-08-31

Completion date

2020-05-31

Last updated

2022-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemiplegia, Stroke

Brief summary

The objective of the current study is to develop and investigate training concepts involving rehabilitation technology, which aim at exploiting the potential for regaining the ability to perform skilled movements by maximizing training intensity and keeping the motivation of patients high. The evaluation focuses on feasibility and cost-benefit analyses

Detailed description

This feasibility project aims to establish an efficient setting for intensive rehabilitation with new technology in four trailblazer clinics. This will enable them to provide intensive therapy to the patients in accordance with the study protocol. If this setting is integrated into the clinical routine, the investigators will be able to collect data to get some first insight into economic and functional data required to calculate changes in socioeconomic costs

Interventions

OTHERRehabilitation technology

* Series of tailored rehabilitative training with the use of new technology which provide feedback and allow for a targeted and intensive and dense training. * With supervision based on patients preconditions and therapy device (e.g. patient/ therapist ratio= 3/1). * A training series lasts four weeks and comprises 3-5 training-days per week. Maximum training break of 7 days. Five sessions of training with duration of 45 min per session, and up to four hours each day are foreseen. * The training can take place in an outpatient or inpatient setting. * Training will be organized in individual one-to-one or group session

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

Inclusion criteria

* Adult patients with residual hemiparesis after cerebrovascular accident * Up to 12 months after the event * Primary rehabilitation terminated * Able to cognitively comprehend the aim of the project with at least 22 points in the Montreal Cognitive Assessment (MoCA) * General health condition allows for intensive rehabilitative training with limited supervision i.e. clearance and prescription of responsible physician * Understand written and spoken German language

Exclusion criteria

Patients with any signs and symptoms showing that the participant is unwilling to participate in the study will result in the patient being excluded from participation Any medical condition preventing participation such as Severe respiratory disease Severe OR unstable cardio-circulatory conditions Orthopaedic conditions, especially in extremities targeted for rehabilitation such as * fixed joint contractures limiting range of motion * non-consolidated fractures Neuro-psychological conditions including cognitive deficits limiting communication or non-cooperation like (self-) aggressive behaviour Infections or inflammatory diseases, like osteomyelitis Specific absolute contraindication for the training with any of the respective devices: * Improper fit of the device, including its harness to relevant extremity(ies) * Contraindicated training position (standing, sitting) Device specific contraindications will be respected and will lead to the exclusion of the device for that patient.

Design outcomes

Primary

Measure	Time frame	Description
Correlation Between Scheduled and Performed Trainings	4 weeks	Adherence was operationalized by correlating planned trainings with trainings which were carried out by the participants. Due to the small sample size Spearman's rank correlation was used.

Secondary

Measure	Time frame	Description
Stroke Impact Scale (SIS) Recovery	Baseline and 4 weeks	Questionnaire to be completed by the patient, regarding different parts in daily life: 1. physical problems: 4 items, 2. memory and thinking: 7 items, 3. mood and emotional control: 9 items, 4. communication and understanding: 7 items, 5.daily activities: 10 items, 6. mobility at home and community: 9 items, 7. hand function: 5 items, 8. participation in life: 8 items. each item should be rated on on 5-point Lickert scale with 1= extremely difficult OR can't do at all OR no strength at all OR all the time AND 5 means: a lot of strength OR not difficult at all OR none of the time OR Question 9 regarding recovery from stroke rated on a scale from 0 - 100 (0= no recovery, 100= full recovery)
Box and Block Test	Baseline and 4 weeks	Measures broader motoric function of the arm and hand as a performance test. Subjects are required to grab and sort wooden blocks from one side of a small dividing wall set up on a table in front of the sitting subject to another side. The unit of the measure is the amount of blocks transferred within 60 seconds.
Functional Ambulation Categories (FAC)	Baseline and 4 weeks	Observer based measurement to rate the ability to walk independently. Rated from 0 to 6 (0= not able to walk independently, 6= can walk independently in every situation)
Functional Independence Measurement (FIM) Generic Functional Performance	Baseline and 4 weeks	observer based measurement of the subject performing basic functional tests, e.g. sitting-up from lying position, stand-up from sitting, walking, stair-climbing etc. Observer rate on a scale from 1 to 7 (1= totally dependent on aid, 7= totally independent) for each activity 18 items, that would led to a score from 18 (totally dependent) to 126 (totally independent)
Walking Index of the Chedoke-McMaster Stroke Assessment Measure (CMSA)	Baseline and 4 weeks	The Walking Index consists of the 5 following items: Walking indoors Walking outdoors, over rough ground, ramps, and curbs Walking outdoors several blocks Stairs Age and sex appropriate walking distance in meters for 2 minutes scored on a 7-point scale (Stage 1 through 7, most impairment through to no impairment, respectively) score from 5 to 35 points, the more points the better
Berg Balance Scale (BBS)	Baseline and 4 weeks	Observer based measurement of walking, standing and balance with 14 items/task to perform by the subject and rated each on scale from 0 to 4 (0= not able to do without help, 4 = can do safely and independently) score between 0 to 56, the more the better
10m Walk Test= TMT Comfortable	Baseline and 4 weeks	time needed to walk 10 m with Comfortable walking speed

Countries

Switzerland

Participant flow

Participants by arm

Arm	Count
Technology Arm 4 Weeks intervention of intensive rehabilitation using rehabilitation technology, 3-5 h per day, within a 5d week in-or outpatient setting. Rehabilitation technology: •Series of tailored rehabilitative training with the use of new technology which provide feedback and allow for a targeted and intensive and dense training. * With supervision based on patients preconditions and therapy device (e.g. patient/ therapist ratio= 3/1). * A training series lasts four weeks and comprises 3-5 training-days per week. Maximum training break of 7 days. Five sessions of training with duration of 45 min per session, and up to four hours each day are foreseen. * The training can take place in an outpatient or inpatient setting. * Training will be organized in individual one-to-one or group session	14
Total	14

Arm

Count

Technology Arm

4 Weeks intervention of intensive rehabilitation using rehabilitation technology, 3-5 h per day, within a 5d week in-or outpatient setting. Rehabilitation technology: •Series of tailored rehabilitative training with the use of new technology which provide feedback and allow for a targeted and intensive and dense training. * With supervision based on patients preconditions and therapy device (e.g. patient/ therapist ratio= 3/1). * A training series lasts four weeks and comprises 3-5 training-days per week. Maximum training break of 7 days. Five sessions of training with duration of 45 min per session, and up to four hours each day are foreseen. * The training can take place in an outpatient or inpatient setting. * Training will be organized in individual one-to-one or group session

Total

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	organizational issues at one study site	1

Baseline characteristics

Characteristic	Technology Arm	—
Age, Continuous	60.8 years STANDARD_DEVIATION 12.5	—
Montreal Cognitive assessment (MoCA)	24.9 units on a scale STANDARD_DEVIATION 2.8	—
Paretic side Left side	9 Participants	—
Paretic side Right side	5 Participants	—
Race and Ethnicity Not Collected	—	— Participants
Region of Enrollment Switzerland	14 participants	—
Sex: Female, Male Female	4 Participants	—
Sex: Female, Male Male	10 Participants	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 14
other Total, other adverse events	0 / 14
serious Total, serious adverse events	0 / 14

Outcome results

Primary

Correlation Between Scheduled and Performed Trainings

Adherence was operationalized by correlating planned trainings with trainings which were carried out by the participants. Due to the small sample size Spearman's rank correlation was used.

Time frame: 4 weeks

Arm	Measure	Value (NUMBER)
Technology Arm	Correlation Between Scheduled and Performed Trainings	0.56 correlation coefficient

Secondary